Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

May 24, 2015 updated by: Jongwon Ha, Seoul National University Hospital

Conversion of Twice-a-day Tacrolimus to Once-Daily Tacrolimus Extended-Release Formulation in Stable Pediatric Kidney Transplant Recipients

This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable pediatric kidney transplant recipients.

Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and after that, the same dose of advagraf will be prescribed. The patients will have another pharmacokinetic study of tacrolimus after conversion to advagraf.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ABO-compatible kidney-only transplantation
  • more than 1 year after kidney transplantation
  • 5 to 15 years old
  • patients maintained on Prograf
  • tacrolimus level of determined previously: 4 to 20 ng/ml
  • eGFR by Schwartz equation > 50mL/min

Exclusion Criteria:

  • patients with acute rejection within 90 days
  • patients with acute rejection requiring antibody therapy within 6 months
  • patients with more than 2 times of acute rejection within 1 year
  • AST/ALT 2 times more than upper normal limit
  • ABO-incompatible or crossmatch-positive transplantation
  • multiorgan transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Advagraf
single group, conversion of prograf to advagraf
Drug: tacrolimus
Other Names:
  • Prograf
  • Advagraf

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Area Under the Curve of tacrolimus pharmacokinetics (AUC0-24)
The investigator will compare the changes in AUC0-24 of tacrolimus, Cmax, Tmax and correlation between C0 and Cmax

Secondary Outcome Measures

Outcome Measure
Number of Participants with Adverse Event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jongwon Ha, MD, PhD, Seoul National University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

July 22, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 24, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adva01SNUH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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